I suppose it was inevitable. In fact, I’m a bit surprised it took this long. SGU Productions, the Society for Science-based medicine, and I are being sued for an article that I wrote in May of 2013 on Science-Based Medicine. My SBM piece, which was inspired by an article in the LA Times, gave this summary:

“The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).”

The claims and practice of Dr. Tobinick have many of the red flags of a dubious medical practice, of the sort that we discuss regularly on SBM. It seems that Dr. Tobinick does not appreciate public criticism of his claims and practice, and he wants me to remove the post from SBM. In my opinion he is using legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.

Of course, we have no intention of removing the post as we feel it is critical to the public’s interest. This is what we do at SBM – provide an objective analysis of questionable or controversial medical claims so that consumers can make more informed decisions, and to advance the state of science in medicine.
We also feel it is critical not to cave to this type of intimidation. If we do, we might as well close up shop (which I suspect the Tobinicks of the world would find agreeable). Defending against even a frivolous lawsuit can be quite expensive, but we feel it is necessary for us to fight as hard as we can to defend our rights and the work that we do here at SBM.

An interesting wrinkle of this suit is that Tobinick is claiming that my blog post is an “advertisement.” This is a legal maneuver as the threshold for forcing someone to remove an advertisement is much lower than the threshold for suppressing their free speech. I can only assume that he and his attorneys are not bothered by the fact that blog posts on SBM are blatantly not advertisements.

In the case of the Enbrel article he had to make the absurd claim that the post (which does not mention my own practice) was an advertisement for my neurology practice at Yale, designed to attack a “competitor.” He would have us believe that Yale neurology in Connecticut is concerned about a distant clinic. Further, Yale Neurology is an academic practice. Our problem is too many referrals and long wait times, not competitors. To see how desperate the claim is, he argued that because I use Botox, which can be used to treat symptoms following stroke, that his treatments for stroke represent a competitor. However, I don’t use Botox to treat stroke patients. I mostly use it to treat migraines, as I am a headache specialist.

Perhaps he feels that my 18 year career promoting science, critical thinking, and science-based medicine is just a cover so I can occasionally attack distant tangential “competitors.”

In any case, the fight is on. Here is a review of the salient points of my criticism of Tobinick:

Tobinick is not a neurologist, and yet he feels it is appropriate for him to treat multiple neurological conditions with an experimental treatment. It is generally considered unethical for physicians to practice outside of their area of competence and expertise. He is trained in internal medicine and dermatology and certified in those specialties. He has never completed a neurology residency nor is he board certified in neurology.

Despite his lack of formal training and certification, he feels he has ushered in a “paradigm shift” in the treatment of Alzheimer’s disease – a disease that has proved challenging for actual neurologists for decades.

His treatment of choice is perispinal etanercept (Enbrel), which basically is an immunosuppressant drug. He is using this treatment for not only Alzheimer’s disease, but neurological deficits following stroke, traumatic brain injury, and pain resulting from vertebral discs. He therefore claims that the neurological deficits in these various conditions result from active inflammation (specifically tumor necrosis factor – TNF) and by inhibiting TNF “rapid improvement” in neurological function is possible.

These claims are highly implausible, and in my opinion reflect his lack of training and expertise as a neurologist. Strokes cause ischemic damage to the brain – brain cells in severe stroke die. Inflammation following stroke is incidental, not causative. Yet Tobinick claims that 10 years following a stroke, long after any neurological recovery would have occurred, patients can improve by inhibiting TNF.

He makes the same claim for Alzheimer’s disease, despite the fact that this is a neurodegenerative disease resulting in loss and destruction of brain cells. An anti-inflammatory drug is not going to bring back dead brain cells, yet he claims “rapid improvement” is possible.

The simplest explanation for the apparent response to his treatments is simply placebo effects. Stroke neurologists, for example, are acutely aware of the so-called “cheerleader” effect. Take a patient with chronic deficits, get them off the couch, give them any treatment and tell them it will make them better, and they will likely demonstrate increased functionality simply because they are making an effort they had not made for a while.

The only way to really know if the treatment itself is having any neurological benefit is with careful double-blind placebo controlled clinical trials. Tobinick, however, has not produced such evidence. He has a long list of publications – all case series, observational studies, pilot studies, case reports, and reviews. I could not find a single double-blind placebo controlled trial establishing the efficacy of his treatment for any of the conditions I listed above. (There are small studies for disc herniation showing conflicting results.)

At best his treatment should be considered experimental. I think the plausibility of the effects he is claiming is extremely low. It’s possible that and anti-TNF effect may be of some use, but given the type of evidence we have it is likely we are seeing mostly (if not completely) placebo effects.

Despite the preliminary nature of his evidence, the “paradigm shift” such claims would represent, and his lack of formal training in neurology, Tobinick has obtained a number of use patents for his treatments. Use patents for medical procedures are still legal in the US, although they have been banned in many other countries, and many consider them unethical. The AMA has this to say:

“The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned.”

The case highlighted in the LA Times story involved Ken Chiate, who brought his wife who was suffering from Alzheimer’s disease to Tobinick’s clinic for 165 injections of Enbrel over four years, at a cost of $800 each (that’s $132,000). During that time there were questionable subjective effects from the treatment, typical of placebo-only effects. Meanwhile his wife continued to relentlessly progress, as is typical of the disease, until she finally died in 2011.
I am not the only one to have concerns about Tobinick’s practices. The Medical Board of California filed an accusation in 2004, amended in 2005 and 2006, stating:

• “From about 2000 to 2002, Tobinick, owned and operated a medical practice under the name “Institute for Neurological Research” in Los Angeles and Newport Beach.
• During those years, Tobinick promoted and advertised a new off-label use for an FDA-approved drug, etanercept (Enbrel). He referred to his drug as DiskCureÂ® and advertised it as “a new and innovative approach for back or neck pain without surgery,” and as a “breakthrough” in the treatment of disc-related back and neck pain.
• Enbrel is a genetically engineered protein and immune response modifier approved by the FDA for treating several types of arthritis but not for back pain. Tobinick’s treatment involved injecting it near the spine.
• Until May 2002, there had been no published, peer-reviewed, scientific studies showing the effectiveness of the treatment for back pain in humans. Nor had there been an approved, pending, or investigational drug application for this use of etanercept.
• Tobinick’s advertisements for DiskCure constituted unprofessional conduct under the California Business and Professions Code.
• Tobinick had also failed to obtain a fictitious name permit for the Institute for Neurological Research as required by law.”

Tobinick agreed to serve 1 year on probation during which he was required to complete courses in ethics and prescribing practices and have his practice monitored by another physician or complete a professional enhancement program.

But now he is not only up to his old tricks, but he has greatly expanded the scope of his Enbrel claims and practice. He has his own “institute for neurological recovery” in which he shows videos of select patients to promote his patented treatments.

This is all, unfortunately, a far too common pattern, one with which we at SBM are very familiar. There is definitely a need here to provide critical analysis of such extraordinary medical claims. That means, also unfortunately, that we will occasionally need to spend our time and resources defending our right to do so.

Is he aware if he went to trial, a gofundme type site would spring up immediately and SBM would have the deepest pockets around to fight his lawsuit. It’s his retirement savings vs about a hundred thousand contributors.

Plus, there’s the publicity that this will undoubtedly engender (positive for SBM and negative for him). Hopefully the judge will just throw this suit out immediately so you don’t have to waste too much money.

My guess is he looked at a donation supported website and decided that there wouldn’t be enough money to stand up to him. He’s betting that all he had to do was spend more on lawyers than you guys are willing to spend and you guys would fold.

Because surely he and his lawyers know that article is not something he can win against.

There are also organizations that help fight bullies using the courts to suppress free speech like Electronic Frontier Foundation and Public Citizen. If it gets too out of hand, perhaps some pro-bono work could be arranged.

I’ve been following Public Citizen’s Paul Levy recently on Twitter, this seems right up his alley.

I’ve watched several of these play out in the e-mail spam fighting arena. The targets of these suits won, but got stuck with considerable legal costs. The highest profile case was Spamhaus v e360 Insight, where the spam source reporting organization was sued for $11/$130/$122/$33 million at various points in the process. As is the usual course of spammers, e360 went bankrupt. Spamhaus escaped significant legal costs because the law firm of Jenner & Block LLP took up the case pro bono publico.

I realize you can’t discuss aspects of the case too much, but can you tell us where it was filed and provide a link?? What damages are they claiming? Are you setting up a defense fund? Hope this goes as well for Tobinick as it did for the BCA and e360 Insight. Or better, that it gets thrown out early on.

Steve, maybe you can help me understand this. How are doctors allowed to practice such unethical medicine? Aren’t there equivalents of the College of Physicians and Surgeons of Ontario out there that can step up and hold these guys accountable and remove their license to practice???? It is so frustrating to hear that in such a highly regulated profession, no one is holding them accountable. Where is the regulation? Where is the enforcement? Seems like the American equivalents of the CPSO have some work to do to investigate various well known Dr.’s whose practice strays very far from the acceptable standard of care.

I know for a fact that other professional regulatory bodies will step in and hammer people if they step so far out of line that they are putting their clients/patients at risk of harm. They will also thoroughly investigate any complaints of wrongdoings. I have seen it first hand among colleagues.

Where is the regulation? Where is the enforcement? Seems like the American equivalents of the CPSO have some work to do to investigate various well known Dr.’s whose practice strays very far from the acceptable standard of care.

America is full of quacks. It’s a highly quacky place. Many of my Canadian uncles and cousins, MDs, defected here in order to practice quackery. Steve or someone else in medicine/healthcare/public-health will have to explain to us the nuances and problems in and between the various state/local regulatory bodies.

The real quacks end up in Florida, because it ain’t quacky enough above the panhandle. Anything goes Florida. Anything…

Florida is very scammer friendly, a great place to invest your ill-gotten gains! Rip off people for millions, invest them in a homestead estate in Florida and those assets cannot be touched by any judgement. http://www.alperlaw.com/asset-protection/florida-asset-protection/homestead-protection/ In the unlikely scenerio that Steve et. al. were to manage to sue for damages for a frivolous lawsuit and win, they might find the guy is broke, but owns a $10 million estate which are untouchable. (Hmm, why did OJ move to Florida?)

Oh, it also doesn’t help that our quacks, when they fail to satisfy their professional regulatory bodies, end up in the Senate. Or the House. Or statehouses. And the stupid money of “special interests”… Wow, we are a quacky place.

I’m guessing people have been thinking about visiting him, googling, and finding negative articles. At least three Yelpers visited him and their own innate skeptical radars went off. Good to see most of them walked out only a little poorer.

Why is this sort of medical quackery allowed to continue? That’s not a rhetorical question; let me elaborate with an example: hate speech is not stamped out because it violates the right to free speech. So, quackery is not actively stamped out because…. What would the downside to this be? Why is it not happening?

Thanks ‘fith’ !!!
I would caution everyone to avoid doing Tobinick’s attorney’s work for him in commentary here or elsewhere. That said…

He’s claiming that Novella’s post is hurting him because it is coming up on Google withing a few hits of his. The search https://www.google.com/search?q=Edward+Tobinick currently returns two hits on him, the very credulous Wikipedia entry on him, then the SBM post.

As mumadadd pointed out, he’s going to get a full dose of ‘Streisand Effect’. I can’t wait to see the Burzynski-ized version of that wikipedia entry, where currently is not heard a discouraging word.

Skeptics tend to be a feisty bunch,so Tobinik had better reconsider if he thinks this will go away with just a blustering threat of legal extortion. He should think about the consequences of likely losing and what his Wikipedia page will say then.And lest he thinks that he will be able to control his Wiki,he should learn from Deepak Chopra et al.
I’ve got your back Steve,just like I did with Simon Singh and Michael Mann. I know that thousands of others will do the same.

They’ve currently raised $16,666 (NZD) to pay for this treatment via donations.

I wrote a letter to the editor of this publication about the ethics of charging such amounts for what should only be considered an experimental treatment, and providing them outside the context of a clinical trial, but unfortunately my letter wasn’t published.

I hadn’t realised a doctor had “use patents” for this treatment, but I presume that means he’s the one acting so unethically. Shocking behaviour for a doctor, his actions make it seem as though he cares more about personal gain then providing ethical and effective medical treatment.

It’s too bad to hear about this. It’s a shameful loss of good resources. Best of luck and I’m with the others on hoping this backfires on him big time.

“How are doctors allowed to practice such unethical medicine? Aren’t there equivalents of the College of Physicians and Surgeons of Ontario out there that can step up and hold these guys accountable and remove their license to practice?”

Agree this should be in place, but will also add that although perhaps it’s slightly better in Ontario or Canada, we (Canada) also give wayyyyyyy too much authority and recognition to SCAMs. Take for example “Naturopathic Doctors” which are unfortunately allowed to use the title of Doctor right now. I think there was a recent SBM post discussing this a little bit. I’m personally ashamed of this type of nonsense in Canada.

IMO just about every country/state/province needs to be harsher on medical BS. All that crap just slows down the progression of real medicine and wastes valuable resources. I’m getting worked up just thinking about it.

The Streisand effect has visited his Wikipedia page. Not a very good edit though. Inserting “as-of-yet highly unproven” into the first sentence is just not right. It changes the meaning of an attributed statement and is just over the top. Gotta be even handed. Just present the facts. If only there were a group whose mission was to improve the skeptical content of Wikipedia pages …

@Argument from the fifth grade, sorry I typo’d your name. I type worse than a fifth grader…

A good first step here (in Australia, not sure if it works like this in the US) is to seek “security for costs”.

Essentially, if you can give the Court a quick-and-reasonable basis for believing the claim is weak and that the plaintiff may not have the means to pay your costs when/if he loses, the Court can order that he (the plaintiff) pays an amount which will be held by the Court pending the outcome of the case. The defendant will be given the money if the plaintiff is unsucessful.

Its a reasonably fair way to ensure that frivolous or hopeless hopeless claims are pursued at the risk of the plaintiff not the defendant, and works to really focus the plaintiff’s mind up-front about the wisdom of pursuing litigation.

@Davdoodles
Given the sheer amount of frivolous litigation in the US (much of which comes from people who should be considered vexatious litigants and banned from the court for constant abuse of the public’s resources) it might be safe to assume that such a reasonable and seemingly effective solution as Security for costs is never practiced in US courts.

“Agree this should be in place, but will also add that although perhaps it’s slightly better in Ontario or Canada, we (Canada) also give wayyyyyyy too much authority and recognition to SCAMs. Take for example “Naturopathic Doctors” which are unfortunately allowed to use the title of Doctor right now. I think there was a recent SBM post discussing this a little bit. I’m personally ashamed of this type of nonsense in Canada.

IMO just about every country/state/province needs to be harsher on medical BS. All that crap just slows down the progression of real medicine and wastes valuable resources. I’m getting worked up just thinking about it.”

I apologize to my US friends if I sounded like Canada is way better with respect to nonsense and medical bs than the American equivalents. Not true. We have plenty of woo, medical nonsense and other horrible things going on here too. Naturopathic doctors in Canada make my blood boil because of the terrible advice that they give people and the fact that, increasingly, people are encouraged by these so-called “doctors” to stop going to real doctors and just take their vitamins and other crap they prescribe.

I was just wondering why the equivalent of the CPSO in the US hadn’t hammered people like this, as well as others like Dr. Oz or that “cancer” doctor (can’t remember his name currently) who treats people with pee.